The World Health Organization (WHO) has announced a change to its in vitro diagnostic prequalification process beginning in 2026. Performance evaluation is no longer included within the prequalification assessment and instead becomes a separate procedure.
WHO prequalification supports manufacturers, regulators, and procurers by assessing quality-assured IVDs for their intended settings. The revised pathway makes early planning more important: product-dossier preparation, labelling review, manufacturing-site inspection, and the applicable performance-evaluation route need to be coordinated as distinct but connected workstreams.
Practical points for manufacturers, distributors, and laboratories
- Confirm the route: identify whether a separate WHO performance evaluation is required for the product.
- Align the evidence: maintain consistent intended-use claims across performance data, labels, and technical documentation.
- Plan procurement carefully: prequalification supports quality-assured selection but does not replace national authorization or local verification requirements.
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